Study of Artifiicial Intelligence-augmented ECG vs. 12-Lead Computerized ECG

Overview

About this study

The purpose of this study is to compare electrocardiograms performed in the downtown Mayo Clinic out-patient practice between two different devices: the remote 12-lead ECG Smartheart Device and the standard of care 12-lead ECG GE Machine.

 

An electrocardiogram, also called ECGs or EKGs, records the electrical signals in your heart. These tests are often done in a doctor’s office, a clinic, or a hospital room. ECG machines are also standard equipment in operating rooms and ambulances. The cost and complexity of existing diagnostic electrocardiography technologies makes them incompatible with widespread stand of care in the primary care settings.

The FDA-approved Smartheart 12-lead ECG Device shows that this standard testing can be performed remotely without the assistance of a well-adverse nurse or technician. This device transmits a single remote 12-lead ECG to an electronic platform for analysis.

Our hypothesis is A.I.-ECG interpretation models will perform similarly or outperform current GE computer ECG interpretation software.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • ≥ 18 years of age.
  • Capacity to consent.
  • Patients undergoing a clinically indicated.

Exclusion Criteria:

  • Unable or not willing to consent.
  • Pregnant women.
  • < 17 years of age.
  • External/Internal Electrical Devices – Left ventricular Assist Device, pacemaker dependence, implantable cardioverter defibrillator, transcutaneous electrical nerve stimulation (TENS) unit, or spinal cord stimulator.  (Rational – interference with interpretation).

Eligibility last updated 10/29/21. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Peter Noseworthy, M.D., M.B.A.

Closed for enrollment

Contact information:

Anthony Kashou M.D.

Kashou.Anthony@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20528569

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